NCT06512259

AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction

A Retrospective Study To Evaluate The Safety And Effectiveness Of AlloMend® Acellular Dermal Matrix Used In Post Mastectomy Pre-Pectoral Breast Reconstruction And Followed For Up To 6-Months Post-Operatively.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: AlloSource · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, retrospective study which will be used to describe and evaluate the effectiveness of AlloMend® Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.

Detailed description

AlloMend® Acellular Dermal Matrix is a sterile, ready to use, human-derived acellular dermal matrix (ADM) allograft that can be used in a number of reconstructive and other surgical procedures. It is made from donated human full-thickness skin. After the epidermal and hypodermal layers are removed, the tissue is treated by a proprietary cleansing process. AlloMend® is intended to be used in conjunction with a breast implant or tissue expander to stabilize implant position and minimize implant loss during post-single or double mastectomy, unilateral or bilateral pre-pectoral breast reconstruction in women 18 years of age or older. AlloMend® may be used in either one-stage (direct-to-implant) or two-stage (expander-to-implant) procedures.

Conditions

• Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy

Interventions

Type	Name	Description
OTHER	AlloMend® Acellular Dermal Matrix allograft	AlloSource, a non-profit supplier of allografts and one of the nation's leading tissue banks, introduced AlloMend® Acellular Dermal Matrix allograft to bring the benefits of regenerative medicine to more patients. cellular allograft matrices, unlike synthetic materials or xenografts, are recognized as human tissue by the body for graft incorporation by the recipient, minimizing the risk of inflammation or rejection. AlloMend® Acellular Dermal Matrix allograft has been shown to incorporate into the surgical site and demonstrates blood vessel infiltration.

Timeline

• Start date: 2023-10-19
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-07-22
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States